American Heart Association In Brief: Cardiovascular Dynamics
This article was originally published in The Gray Sheet
Executive Summary
Cardiovascular Dynamics: Launches its ARC (Active Response Catheter) and Lynx F/X catheters at the AHA scientific sessions. The ARC device, approved by FDA in June, incorporates CVD Focus technology to "provide a versatile device that can perform interventional coronary procedures using both low and high balloon inflation pressures on a single catheter," CVD says. Shipments are slated to begin by the end of 1996. The Lynx F/X catheters, launched at AHA to European and Japanese physicians, feature a smaller catheter shaft and a reduced balloon profile than its previous devices. The Lynx device also features CVD's extended-pressure Focus balloon technology, which allows the product to be used in procedures "requiring moderate and high pressure dilatation." The Lynx F/X will not be launched in the U.S. due to patent restrictions regarding its rail design; however, the firm expects an over-the-wire version to be available in early 1997 following FDA PMA supplement approval...